Cel Sci Corporation New (CVM) News

Well - we're about half through 'the month' now and we could use some positive news,....

Wow. Well if either of these go anywhere you should be good. I wish you luck my freind.

I have 41k shares of NWBO and unfortunately 30k shares of this pos

Yesterday's daily short sale volume was 68.62% (as reported by FINRA) but despite all the manipulations by the shorts, the PPS went up 0.56%! The short borrow fee is still at 13.28%! With all the facts and clarifications that we got in the latest Letter to Shareholders and the news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts still have a position of currently 6.97 million shorted shares (short float of 13.34%). The CEO promises us an interesting month: "We are looking forward to a month filled with several very important meetings designed to bring our cancer therapy Multikine to market. We will keep you updated on our progress." I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!!

Been in this one for a long time. Same with NWBO. One of these companies has to come to approval at some point… this is taking way too long. Makes me wonder if either is going to actually be a success. I want them both to work out but it is taking alot of patience. Just venting…..maybe we get a miracle this coming week? Praying…

That's what toxic financing will do to ya.....I warned people here years ago.

Not a great day for us shareholders,... I wonder what the 'looming' bad news is that's driving this?

CVM under $2

I think that LEAPS has a ton of potential. That's a fact. However, LEAPS is a developmental-stage platform that's many years, and lots of $$s away from being anything other than a developmental-stage platform.

If Multikine doesn't pull this company up and start generating revenue, LEAPS will never be more than just a clever idea.

Leaps Technology rising from the dead. New article out.

I just read an article on Pfizer’s investor conference:

“Pfizer plans to focus on four main types of cancer: breast cancer; genitourinary cancer, which impacts urinary and genital organs or functions; thoracic cancer, such as lung, head and neck cancer; and hematology-oncology, or cancers of the blood, such as multiple myeloma and lymphomas.”

They also said they are moving away from the lab/small molecule meds and getting into more of the biologics…..

Sorry if this is redundant or old news but it would be nice if they just bought CVM out or at least went into a partnership. CVM appears to be exactly they type of new product they are trying to get in too. What is the hold up?? This is taking a crazy long time.

IMO you're on the right track with your bit about the history of drawn-out finance deals. But I would assert that in addition the long, long, long delays in getting their Phase III rolling soiled the management's reputation. That initial CRO flaking out on them really put a crimp on their getting the trial ramped up - that cost them a couple of years, a lot of both financial and social capital.

Then the study post-treatment period ended up being longer than was stated it would be. Then it took forever to get the data locked, analyzed, and the initial whole-cohort population (as a whole) didn't appear to meet the primary endpoints for success. Then it took them what seemed like years to get the biomarkers for the target subpopulation and the patient assessment criteria in place.

Recent financing of operations has at least been generally transparent. In the past, that definitely could not be said to be true.

They do appear to have at least most of their ducks in a row and marching steadily forward now. That's promising.

Yes, i think it has hurt them, however for such a small bio company to stay in business for as long as they have, and accomplish what they have done w/o a big partner is remarkable. You can't build a successful company without a great deal of money. I think we are in the home stretch with the finish line in sight.

Just my opinion of course.

I typically have a great feel for if a company is legit or not, but this one has kept me confused.
The company puts out a great report, however, apparently no one is buying into it.
The only thing that makes any sense at all is all those toxic finance deals they've done in the past are killing them. I don't know if this is still how they are financing their operations.

It's a very positive letter for us shareholders, the company, and potentially for a lot of cancer patients.

It's only a matter of time now. :D

CEL-SCI Corporation Issues Letter to Shareholders

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.

Dear CEL-SCI Shareholders:

Last year we successfully moved our investigational Multikine® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times. The results from our Phase 3 trial presented us with a conundrum in that we had great survival data with Multikine as a pre-surgical treatment in head and neck cancer when followed by surgery and radiotherapy only, but not when followed by surgery, radiotherapy, and chemotherapy. The key issue was how to determine who should be treated with Multikine, which is given before surgery, while the determination of who gets chemotherapy added to their treatment is made after surgery. We solved this issue with great success and presented the selection criteria at a major oncology conference:

CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance. In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The target population, which saw its 5-year risk of death cut in half, can be identified prior to surgery upon diagnosis with tests that physicians routinely use in cancer screenings, a key finding for Multikine, which is a neoadjuvant therapy. A summary of Multikine’s results in the target population include the following:
Risk of death cut in half at 5 years vs. control
73% survival for Multikine vs 45% in the control at 5 years
28.6% absolute 5-year overall survival benefit versus control; statistically significant p = 0.0015 and hazard ratio = 0.35
Tumor reduction rate >13% and tumor downstaging >35%
Low PD-L1 tumor expression (as compared to high PD-L1 where Keytruda and Opdivo work best)
No safety signals or toxicities vs standard of care
Target population is an estimated 145,000 patients (global, annual) with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who present with:

No lymph node involvement (via PET scan)
Low PD-L1 tumor expression (TPS

I disagree that he is bearish

That author is usually fairly bearish - but this article is relatively evenhanded for him/her.

https://stocktwits.com/NavyPatrol657/message/561244708

Anyone have access to the 2/12 CVM story on Seeking Alpha? You have to be a Premium member to see it. If so, could you post it here?

Depends totally on the financing arrangements.

Someone just invested $7.2 MM in CVM. Would they do this if they were not confident in getting to see results?

You armchair CEO’s are a dime a dozen. Why the hell would he do a huge offering at a 28% discount when they are certain marketing is soon. Smart move would be small incremental steps up the ladder. How the hell did you come up with 40%. What the hell ever anyway , sell button is in same place it always was. Have at it. Or buy up offering yourself!

No....it's a BIG discount! Well maybe in the penny stock world its about right, but can you imagine say GOOG doing an offering at $100 while trading at $150?
Looks like CVM used them last year as well.
If I were a shareholder, I'd sure be looking closer at how the money is being used.

One can debate if a 15% offering was a bit discount. But this was a 40% discount. $2 when the stock was over $2.8 for the last several weeks.

And for a measly $7.2M? Generally when the discounts are large they raise enough cash to live off for a year or more.

I don’t think 25-28% is a HUGE discount. Actually pretty normal for a cash raise.

When you can’t borrow from conventional lenders, the offering is usually at a huge discount to current stock price in order to make the deal. It allows the buyer an opportunity to immediately profit if there are no restrictions on the new stock (and it’s totally possible the buyer or some of its affiliates had short positions as this deal was being negotiated) .

For the company, selling shares is a cheaper alternative than paying interest with cash you don’t have (not that any bank will lend additionally to them at this time).

Approval of their drug is the only way out of this mess. Even then, is the market large enough?

Geert hitting his personal ATM again.

Assuming that the potential buyer would pay a higher price for the shares.....

You can dilute with less shares at a higher price

Maybe they can't. Dumping company stock isn't going to help you any.

You may want to look into this company. They're the ones who set the price.

https://www.think-equity.com/

This isn't the first time CVM has used them. Perhaps go check on the other companies they've done deals with, to see how the share prices are doing.

Well that ain't good for the shareholders

I think they are just too stupid to figure it out. You can dilute with less shares at a higher price…come on man!!

I absolutely get the need to raise money - but why do the keep undercutting the market by so much when they do so? Ugh.

Might have to use this opportunity to gather in some more shares at a discount next week though.

Gerty is famous for screwing the share holders. Looks like he did it again. A $2 offering when the stock was $3. Glad I am on the sidelines here, he has been screwing people for many many years.

CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock
February 09, 2024 08:30 AM Eastern Standard Time
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital.

ThinkEquity is acting as sole book-running manager for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement, when available, and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head
9:00 AM ET 2/6/24 | BusinessWire

Marks key achievement that is a prerequisite to filing a Biologics License Application with the FDA and other regulators for marketing approval
VIENNA, Va.--(BUSINESS WIRE)--February 06, 2024--

CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine(R) (Leukocyte Interleukin, Injection)* cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed.

"This is a very significant milestone in bringing Multikine to market since the manufacturing facility is part of a planned Biologics License Application required for approval of Multikine in the treatment of head and neck cancer," stated CEL-SCI's CEO Geert Kersten.

"The high degree of complexity involved in manufacturing Multikine has required tremendous investment and time on CEL-SCI's part. Our manufacturing trade secret, capability, and know-how are high-value key strategic assets that would be very difficult for others to replicate. This achievement marks a very big step towards the preparation of Multikine for marketing approval," Kersten added.

Originally constructed to supply Multikine for the world's largest global pivotal Phase 3 trial in locally advanced squamous cell carcinoma of the head and neck, CEL-SCI's facility has been expanded and upgraded in preparation for the Company's submission of Multikine for regulatory approval and commercial scale manufacturing. In keeping with CEL-SCI Validation Master Plan, industry standards, International Society for Pharmaceutical Engineering (ISPE) guidelines, International Conference for Harmonization (ICH), and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility's utilities, systems, and equipment.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target population, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the progress and timing of, and the amount of expenses associated with, our research, development and commercialization activities for our product candidates, including Multikine; (ii) our ability to duplicate the clinical results demonstrated in clinical studies, (iii) the timely development of any potential products that can be shown to be safe and effective, (iv) receiving necessary regulatory approvals, (v) difficulties in manufacturing any of the Company's potential products, (vi) our liquidity and ability to raise the necessary capital on acceptable terms, if at all. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the fiscal year ended September 30, 2023 filed with the SEC on December 21, 2023 and the other reports we will with the SEC. You are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this press release. As a result of these matters, changes in fact, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. The forward-looking statements made in this press release are made only as of the date of this press release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240206088192/en/

CONTACT: Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024

I dunno. I'm not a shareholder or planning to buy any shares. Just a somewhat interested observer.
From what I've seen of the past, there have been many fake outs and lost promises.
I'm too lazy on this one to make the effort to truly determine if it's a real company or not.
With that said, currently they are going to continue to lose a lot of money per share for quite some time, but technically, there is no resistance until (I'll say) somewhere just over $7.
Personally, I'm not a buyer of stocks that lose money.

NEWS OUT- causing stock to be “in-play” and going up

https://feeds.issuerdirect.com/news-release.html?newsid=7643495042413725

European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine®
CEL-SCI has cleared a significant hurdle that mandates cancer drugs in Europe comply with strict requirements for pediatric usage and clinical evidence

CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). According to the opinion letter:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240131910101/en/

The volume was back in October. The short term chart does show the potential for a decent move. ...with a stop loss at $2.20

Nice move today on decent volume. Something brewing??

I had to laugh when I read your post and then saw your “signature” quoting Tolstoy about patience. Lol.

And more nothing and it's almost February,....

It has bounced upwards off support. Wouldn't panic yet.

As soon as I bought this is goes down

Merck has trailing 12 months total revenue of $59.3 billion. Its yearly revenue from Keytruda is $20.9 billion. Merck is not the same company without Keytruda. It has been demonstrated that the collaborate use of MultiKine and Keytruda would extend the patent on Keytruda by 5 years-which is expiring in 2028. Keytruda works with a high PD-L1 marker (30% of patients) and MK works with a low PD-L1 marker (70% of the patient population). This collaboration appears perfectly suited, and so, inevitable.

Considering support is at $2.45, you may be right .....today. Maybe not tomorrow though.

Very dumb to sell here. January ema feedback saying yes to immediate approval puts this at $30 minimum

CVM Chart

Last minute tax loss selling--and now it is over.

Well - doesn't look that we are going to hold above $3 for the moment anyway. I'll be pleasantly surprised though if we do. However, it does generally look like the company is heading the right directions going into 2024.

Thanks for the reply. This seems to pop every once in a while for no reason and then settles back down to where it started. 🤷‍♂️